Vital Signs™ B1714XXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10190752124004), received between Jan 24, 2023 and Jul 6, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN THE PATIENT WAS SEDATED FOR INTUBATION THE ENDOTRACHEAL (ET) TUBE WAS PLACED BY ANESTHESIA AND HOOKED UP TO THE CIRCUIT.WHEN THE PATIENT WAS MANUALLY VENTILATED, IT SOUNDED LIKE THERE WAS A LEAK IN THE B1714XXX ANES CIRCUIT, PED, 108 IN EXP, 1L BAG. THE ANESTHESIOLOGIST NOTED THERE WAS NOT GOOD VENTILATION. THE PATIENT WAS EXTUBATED AND VENTILATED USING A BAG VALVE MASK WHILE THE CIRCUIT TUBING AND BAG WERE REPLACED. AFTERWARDS, THE SOUND OF THE LEAK WAS GONE AND BETTER VENTILATION WAS ACHIEVED. MORE MEDICATION WAS PROVIDED TO SEDATE FOR INTUBATION WAS DONE AND THE ET WAS REPLACED WITH GOOD SEAL IN THE TUBE AND THE CIRCUIT WAS VENTILATING AS IT SHOULD BE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263966 ↗
• InjuryMay 24, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX -ANES CIRCUIT, PED, 108 IN EXP, 1L BAG HAS HOLES IN THE CIRCUIT CAUSING AN AIR LEAK. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990310 ↗
• InjuryMay 24, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX -ANES CIRCUIT, PED, 108 IN EXP, 1L BAG HAS HOLES IN THE CIRCUIT CAUSING AN AIR LEAK. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990309 ↗
• MalfunctionMay 24, 2023Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX - ANES CIRCUIT, PED, 108 IN EXP, 1L BAG WERE NOT PASSING THE LEAK TESTS ON MACHINES DUE TO HOLES AND CRACKS IN THE CIRCUIT HOSE.THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990298 ↗
• MalfunctionMar 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX ANES CIRCUIT, PED, 108 IN EXP, 1L BAG WAS LEAKING. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. THERE WAS NO HARM BUT THIS ISSUE CAUSE A DELAY OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583707 ↗
• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX ANES CIRCUIT, PED, 108 IN EXP, 1L BAG WAS LEAKING. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. THERE WAS NO HARM BUT THIS ISSUE CAUSE A DELAY OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554710 ↗
• MalfunctionMar 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE B1714XXX ANES CIRCUIT, PED, 108 IN EXP, 1L BAG WAS LEAKING. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. THERE WAS NO HARM BUT THIS ISSUE CAUSE A DELAY OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554284 ↗
• InjuryJan 24, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE ANESTHESIOLOGIST WAS UNABLE TO GIVE POSITIVE PRESSURE VENTILATION WITH THE ANESTHESIA MACHINE WHILE VITAL SIGNS¿ PEDIATRIC ANESTHESIA BREATHING CIRCUIT WAS IN USE. THE PATIENT WAS SUCTIONED, RE-INTUBATED, AND WAS CONTINUED TO BE VENTILATED BY BAG VALVE MASK. THE CUSTOMER CONFIRMED THAT NO HARM WAS DONE TO THE PATIENT BECAUSE THE ANESTHESIOLOGIST WAS QUICK TO GIVE MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236151 ↗